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Interoperability & QoS Implications of ISO TC215 WG2.1

Interoperability & QoS Implications of ISO TC215 WG2.1. Todd Cooper (t.cooper@ieee.org) Chairman, IEEE 1073 Technical Director, MDCIG / IEEE-ISTO President, Breakthrough Solutions. Overview. ISO TC215 Interoperability & QoS. TC215 WG 2.1 X73 Standards.

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Interoperability & QoS Implications of ISO TC215 WG2.1

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  1. Interoperability & QoS Implications of ISO TC215 WG2.1 Todd Cooper (t.cooper@ieee.org) Chairman, IEEE 1073 Technical Director, MDCIG / IEEE-ISTO President, Breakthrough Solutions

  2. Overview • ISO TC215 Interoperability & QoS • TC215 WG 2.1 X73 Standards • QoS for Point-of-Care Medical Device Communication Workshop on Standardization in E-health

  3. ISO TC 215 Interoperability • Interoperability : ability of two or more systems or components to exchange information and to use the information that has been exchanged. source : IEEE Standard Computer Dictionary : A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990 • Functional interoperability Shared Architectures, Methods & Frameworks • Semantic interoperability Shared data types, terminologies, codings Workshop on Standardization in E-health

  4. ISO TC 215 Interoperability • WG 1: EHR architecture and modeling • WG 2: Messaging architecture & methods • WG 3: Terminology Methods • WG 4: Shared security architecture • WG 5: Shared health card framework Workshop on Standardization in E-health

  5. ISO TC 215 Interoperability • For Quality of Service : WG 1 - Health indicators conceptual framework WG 2 - Quality indicators for health information made available on the Internet Workshop on Standardization in E-health

  6. ISO TC215 Health Informatics • Focus is primarily on Level 7 Interoperability • Medical Device Communications covers all 7 layers. Workshop on Standardization in E-health

  7. ISO TC215 Health Informatics Workshop on Standardization in E-health

  8. Completed Published Standard Develop and Ballot Draft Using IEEE Process Standard fails ISO DIS/FDIS ballot Draft passes IEEE ballot Ballot Approved IEEE Document Using ISO Process (DIS/FDIS) Draft passes ISO DIS/FDIS ballots Publish ISO/IEEE/CEN Standard ISO/IEEE/CEN X73 Process Establish Work Plan for Standard (incl. resolution of all issues between IEEE, ISO, and CEN) Workshop on Standardization in E-health

  9. ISO/IEEE 11073 Standards X73 Charter: Provide real-time plug-n-play interoperability for patient-connected medical devices Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care, in all health care environments …leveraging off-the-shelf technologies, scaling across a wide range of system complexities, and supporting commercially viable implementations. Workshop on Standardization in E-health

  10. ISO/IEEE 11073 Standards Primary focus is on… Point-of-Care (POC)… Medical Device… Communications ISO/IEEE 11073 Health informatics – Point-of-care medical device communications - … Workshop on Standardization in E-health

  11. ISO/IEEE 11073 Standards X73’s architecture ensures… • True interoperability across all 7-layers: From the connector to the end application!  QoS mechanisms designed to support the strong requirements placed on regulated medical devices  Maintainability as communications technology and applications change Workshop on Standardization in E-health

  12. ISO/IEEE 11073 Standards Workshop on Standardization in E-health

  13. ISO/IEEE 11073 Standards Medical Device Data Language (MDDL): Semantics needed to communicate a device’s application status and control information. Consists of three main components: • Nomenclature (1073.1.1.1) • Domain Information Model (DIM) (1073.1.2.1) • Device Specializations (1073.1.3.x) Workshop on Standardization in E-health

  14. ISO/IEEE 11073 Standards Nomenclature: A set of numeric codes that identify every item that is communicated between systems. Workshop on Standardization in E-health

  15. ISO/IEEE 11073 Standards Domain Information Model: An object oriented data model that specifies objects, attributes, attribute groups, event reports, and services that may be used to communicate device data and to control / configure the reporting of information. • Does not imply a specific implementation technology • Objects include Medical Device System, Virtual Medical Device, Numeric, Enumeration, Real-Time Sample Array, Battery, Scanners, Alert Monitor, … Workshop on Standardization in E-health

  16. ISO/IEEE 11073 Standards Domain Information Model Subject Areas Workshop on Standardization in E-health

  17. ISO/IEEE 11073 Standards Workshop on Standardization in E-health

  18. ISO/IEEE 11073 Standards Generalized application profile standards … • A generic (non-device specific) set of data and services needed to initiate, configure, and maintain communication. • Connect ~ Disconnect, Create ~ Delete, Get ~ Set, Event Report, Invoke, etc. • Standard Services: ACSE, ROSE, CMISE, ASN.1, MDER (based on BER+), Etc. • Beginning work on XML & Web Services profile Workshop on Standardization in E-health

  19. ‘On-the-Wire’ Format Abstract Syntax (ASN.1) Transfer Syntax (MDER) ISO/IEEE 11073 Standards Domain Information Model Workshop on Standardization in E-health

  20. ISO/IEEE 11073 Standards Generalized application profile standards … • Profiles: • Specific set of capabilities tailored for a class of communication needs / architectures • Limits the options that are available • Remaining options must be discovered and in some cases negotiated when a connection is made (enabling plug-n-play interoperability!) Workshop on Standardization in E-health

  21. ISO/IEEE 11073 Standards Workshop on Standardization in E-health

  22. ISO/IEEE 11073 Standards Available (point-to-point) transport standards… • IrDA-Based Cable Connected (1073.3.2) • IrDA-Based Infrared Wireless (1073.3.3) Transport standards (LANs) under consideration… • RF Wireless – high emphasis on QoS! • IP-Based (Ethernet) Key: Shared IT infrastructure with guaranteed QoS Workshop on Standardization in E-health

  23. Examples: LAN Access Points, Wired-to-Wireless Transport Gateways, ISO/IEEE 11073 Standards Workshop on Standardization in E-health

  24. ISO/IEEE 11073 Standards Objective: Interoperability between different application-layer protocols + Bi-Directional Transparency Example: HL7 / IEEE Gateway: IEEE 1073.6.1.1 … HL7 - Observation Reporting Interface! Workshop on Standardization in E-health

  25. ISO/IEEE 11073 Standards 1073 System 1073 Network HL7 Network HL7 System HL7/1073 Gateway 1073 System HL7 System HL7-IEEE JWG Project Scope: Identification and definition of interfaces to support interoperability between HL7 and 11073 based systems for Point-Of-Care testing / monitoring use cases. Workshop on Standardization in E-health

  26. ISO/IEEE 11073 Standards • X73 – Real-time plug-n-play interoperability across all 7-layers • From Device-to-device up to Device-to-EMR Workshop on Standardization in E-health

  27. ISO/IEEE 11073 Standards X73 includes QoS management support: • Negotiated Bandwidth at association  Start-up configuration minimizes network usage to that which is needed for client applications.  Management Information Bases (MIBs) provide dynamic visibility to communications performance  State models and confirmed delivery provide a high level of reliability for medical data transfer Workshop on Standardization in E-health

  28. ISO/IEEE 11073 Standards Drivers of X73 QoS: • Regulated industry: “Safe & Effective”  Clinical Use Cases for devices – esp. real-time requirements: User needs & expectations!  Transport and service profile technologies (LAN based vs. point-to-point)  System wide topologies (local vs. wide area)  Non-clinical stakeholders (…finance) Workshop on Standardization in E-health

  29. ISO/IEEE 11073 Standards Key X73 QoS considerations: • Reliability – FMEA, error detection & mitigation  Latency – from device detection to end annunciation for the data client  Priority – Not all medical device data has the same communications priority  Bandwidth – Allocation and dynamic management Workshop on Standardization in E-health

  30. ISO/IEEE 11073 Standards • Alerts (both physiological & technical) X73 Data Categorization:  Real-time Waveforms  Real-time Parameters (Breath-to-breath)  Non-RT Parameters (battery level, metric label)  Non-RT Event (low battery)  Controls  History / Archival  Web Browsing Workshop on Standardization in E-health

  31. Workshop on Standardization in E-health

  32. ISO/IEEE 11073 Standards • Latency: Prioritization support Shared Bandwidth management architecture (across multiple manufactures / devices) X73 QoS Issues: • Reliability: Prioritization policies – guaranteed B/W Network fault detection & Annunciation  Graceful system performance degradation  Co-existence Management (esp. RF wireless) Workshop on Standardization in E-health

  33. ISO/IEEE 11073 Standards And what about… • Remote Control: a virtual plug-n-play remote control network! • Global access: Real-time vital signs viewing across the world (w/security, authentication, …) Workshop on Standardization in E-health

  34. ISO/IEEE 11073 Standards • X73 are the only comprehensive point-of-care medical device communication standards on the horizon! Conclusions…  Need additional pilot projects to show capabilities of X73 protocols  Health care providers and management organizations must demand medical device interoperability using X73  We welcome support in adding security, web services, and rigorous LAN-based QoS support to our standards Workshop on Standardization in E-health

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